Urinary incontinence, or involuntary urine outflow, affects sixteen percent of women in the United States of America. In about seventy five percent of these women, urinary incontinence occurs when the pressure in their abdomen, called the intra-abdominal pressure, or IAP, rises above a threshold pressure, called IAP1; this is called stress incontinence. In about twenty percent of incontinent women, the detrussor muscle of the urinary bladder involuntarily contracts, producing a sudden urge to urinate; this is called urge incontinence. Women with both stress and urge urinary incontinence are said to have mixed urinary incontinence.
While pharmaceutical treatment is available to relax the detrussor muscle and relieve urge urinary incontinence, there are no pharmaceuticals cleared by the U.S. Food and Drug Administration for treating stress urinary incontinence. Many surgical procedures have been developed to mechanically support the human female urethra or to make it more rigid, but these are expensive, have side effects and are chosen by very few incontinent women. Devices to temporarily block urine flow using a urethral catheter whose proximal end expands inside the bladder need to be replaced every time the woman urinates, and are relatively expensive. Palliative measures, such as wearing an absorbent pad and changing it after every urination, are not only expensive but may leave the skin on the inner thighs wet, leading to abrasions and ulcers; while many pads contain deodorants, the residual urine odor is embarrassing for many incontinent women, leading to restricted social contacts and decreasing their quality of life.
Prior art includes devices inserted through the female urethra into the bladder to seal the bladder neck until the devices are removed, and a device containing a manually operated drainage control valve that is inserted through the female urethra into the bladder as disclosed in U.S. Pat. No. 5,234,409.